Bladder CancerPhase 1NCT01373398
Safety and Pharmacokinetic Study of EO9(Intravesical Instillation)
A Phase 1 study testing EO9(Apaziquone) in people with Bladder Cancer, run by Handok Inc. at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC). Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- EO9(Apaziquone)
- How many people
- 11 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2011to Feb 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder
- Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT.
- P.S : 0-2 according to the ECOG.
Who cannot join
- Patients with a primary and solitary tumor.
- CIS lesions in the bladder or a history thereof.
- Grade 3 disease or a history thereof.
- Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
- Patients having stage T1 and high-grade disease.
- Invasive cancer of T2 or greater, with definite lymph node or other organ metastasis, or a history thereof.
Show all 12Show fewer
- Patients who received intravesical chemotherapy/immunotherapy treatment within 6 months prior to the present TURBT.
- Patients who underwent systemic chemotherapy or radiotherapy whose field of exposure included the bladder.
- Patients with suspected bladder perforation at the time of the present TURBT.
- A complication of a malignant tumor of the upper urinary tract or urethra, or a history thereof.
- Malignancy within 5 years other than NMIBC (except thyroid cancer)
- A serious viral or bacterial infection within the last 4 weeks.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Bladder Cancer
- Being tested
- EO9(Apaziquone)
- Keywords
- bladder cancer, EO9, Apaziquone
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO9(Apaziquone)Drug
immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
Measured: 14 weeks
Secondary outcomes (1)
pharmacokinetics assessment of EO9 and it's metabolites in blood and urine
Measured: before, 30, 55, 90 mins of EO9 instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Handok Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373398
- Sponsor's protocol ID
- HD901_01
- Status last verified
- Mar 2012
- First submitted
- 9 Jun 2011
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetics of Intravesical Instillation of EO9 in Patients With Non-muscle Invasive Bladder Cancer(NMIBC)
- ClinicalTrials.gov ID
- NCT01373398
- Acronym / sponsor ID
- HD901_01
- Conditions
- Bladder Cancer
- Keywords
- bladder cancer, EO9, Apaziquone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Handok Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of intravesical instillation of EO9 in patients with non-muscle invasive bladder cancer (NMIBC).
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are clinically diagnosed as having stage Ta, T1, histological grade G1, G2 urothelial carcinoma of the bladder
- Patients who are confirmed to be urinary cytology negative (class I, class II) within 4 weeks prior to the present TURBT.
- P.S : 0-2 according to the ECOG.
Key exclusion criteria (12 listed)
- Patients with a primary and solitary tumor.
- CIS lesions in the bladder or a history thereof.
- Grade 3 disease or a history thereof.
- Patients experiencing recurrence within 3 months following TURBT for prior NMIBC.
- Patients having stage T1 and high-grade disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EO9(Apaziquone)immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone | Drug | – |
Primary outcome
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.)
Time frame: 14 weeks
1 secondary outcome
pharmacokinetics assessment of EO9 and it's metabolites in blood and urine
Time frame: before, 30, 55, 90 mins of EO9 instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EO9(Apaziquone) in people with Bladder Cancer, run by Handok Inc. at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment based on all Adverse events(causal relationship, incidence, severity, etc.) (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2012.